Peptide-coupled Red Blood Cells for the Treatment of Multiple Sclerosis
Launched by CELLERYS AG · May 21, 2024
Trial Information
Current as of February 08, 2025
Recruiting
Keywords
ClinConnect Summary
The RED4MS clinical trial is studying a new treatment for relapsing-remitting multiple sclerosis (RRMS), a type of MS that causes symptoms to come and go. This trial tests a therapy called CLS12311, which uses the patient's own red blood cells modified with special proteins to help the immune system tolerate the disease better. The main goals of the trial are to ensure the treatment is safe, well-tolerated, and effective for managing RRMS.
To participate in this trial, individuals must be between 18 and 55 years old, have been diagnosed with RRMS for less than 10 years, and have experienced at least one relapse in the past year. Participants will be monitored closely during the study, and both men and women will need to use effective contraception during the trial. It’s important to note that certain health conditions may exclude individuals from participating, such as other immune disorders or recent treatments for their MS. Overall, this trial offers a potential new approach to help manage RRMS and could contribute to future treatment options.
Gender
ALL
Eligibility criteria
- Inclusion Criteria (Part A and B):
- • 1. RRMS according to the 2017 McDonald criteria
- • 2. Male or female patients (assigned at birth) aged 18-55 years inclusive
- • 3. Disease duration (since diagnosis) \<10 years
- • 4. Expanded Disability Status Scale (EDSS) at baseline 0-5.5
- • 5. ≥1 relapse or new CEL/T2 in previous 12 months (only Part B)
- • 6. Untreated patients or patients being off therapy for the time-periods listed under exclusion criterion No. 2. Patients are either not eligible to receive approved therapies or have explicitly chosen not to receive such therapies after being adequately informed by the investigators
- • 7. Only for female patients of childbearing potential (sexually mature, pre-menopausal and not surgically sterile): the patient is willing to use a highly effective method of contraception throughout the treatment phase or at least for 4 weeks after the last dose of the study drug
- • 8. Male patients willing to use contraception (such as a condoms) throughout the treatment phase or at least for 4 weeks after the last dose of the study drug, unless surgically steril
- Exclusion Criteria (Part A and B):
- • 1. Patients with an active chronic disease (or stable but treated with immunomodulatory/-suppressive therapy) of the immune system other than MS (e.g. rheumatoid arthritis, scleroderma, Crohn's disease, ulcerative colitis, etc.) or with a known immunodeficiency syndrome (AIDS, hereditary immune deficiency, drug-induced immune deficiency)
- • 2. Prior treatment with any of the medications specified in the protocol
- • 3. History of HIV, chronic or active Hepatitis, chronic or active Hepatitis B or Syphilis
- • 4. Long-Covid19 syndrome
- • 5. History of splenectomy or chronic liver disease
- • 6. History of coronary artery disease, chronic heart failure, aortic stenosis
- • 7. Current anticoagulation therapy
- • 8. Uncontrolled grade II hypertension (≥160 systolic and/or ≥100 diastolic blood pressure according to the International Society of Hypertension (ISH) guidelines) despite treatment or without treatment
- • 9. History of stroke
- • 10. Pregnant female confirmed by a positive pregnancy test or breast-feeding
- • 11. History of alcohol or drug abuse within the 1 year prior to screening visit 1
- • 12. History of or existing malignancy within the last 5 years prior to enrolment except history of basal cell carcinoma and melanoma in situ
- • 13. History of or existing relevant central nervous system disorder (other than MS)
- • 14. Allergy to gadolinium-based contrast agents
- • 15. Any other disease or condition, which could interfere with the participation in the study according to the study protocol, or with the ability of the patients to cooperate and comply with the study procedures.
- • 16. Anemia, defined as hemoglobin levels ≤12.5 g/dl (7.25 mmol/l) for female and ≤13.5 g/dl (8.37 mmol/l) for male participants (may be repeated if 11.5-12.5 g/dl in females and 12.5-13.5 g/dl in males)
- • 17. Erythrocyte count \<4.0 E12/L in female and \<4.5 E12/L in male patients (may be repeated if \>3.8 E12/L in female and \>4.3 E12/L in male)
- • 18. Lymphopenia with total lymphocyte counts ≤1000/µl (may be repeated if \>800/µl)
- • 19. Positive HIV testing
- • 20. Positive results of baseline period testing for serological markers for hepatitis B, C, and Syphilis indicating acute or chronic infection
- • 21. Patient is not eligible for blood donation according to local regulations
- 22. Having one or more of the following laboratory results:
- • 1. Estimated glomerular filtration rate (eGFR)\< 60 mL/min/1.73 m2 (may be repeated if eGFR 45-59 mL/min/1.73 m2)
- • 2. ALT or AST \>3x upper limit of normal (ULN; may be repeated if 3.1-4x ULN)
- • 3. Total bilirubin greater than 2x ULN (may be repeated if 2.1-3x ULN), with the exception for patients with Gilbert's disease
- • 4. Platelet count ≤100x109/L (may be repeated if 80-100x 109/L)
- • 5. Abnormalities in hepatic synthetic function tests as judged by the Investigator to be clinically significant
About Cellerys Ag
Cellerys AG is a forward-thinking biopharmaceutical company dedicated to innovating therapies that harness the power of cellular technologies to address unmet medical needs. With a focus on developing advanced cell-based treatments, Cellerys AG combines cutting-edge research with a commitment to quality and safety in clinical development. The company's mission is to improve patient outcomes through precision medicine, leveraging its expertise in cellular biology and a robust pipeline of products aimed at transformative care solutions.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Ulm, , Germany
Florence, , Italy
Leipzig, , Germany
Praha 5, , Czechia
Praha, , Czechia
Mannheim, Baden Württemberg, Germany
München, Bayern, Germany
Göttingen, Niedersachsen, Germany
Münster, Nordrhein Westfalen, Germany
Dresden, Sachsen, Germany
Hamburg, , Germany
Zürich, , Switzerland
Zürich, , Switzerland
Florence, Tuscany, Italy
Hradec Kralove, , Czech Republic
Prague, , Czech Republic
Berlin, , Germany
Genoa, , Italy
Padova, , Italy
Rome, , Italy
Bern, , Switzerland
Praha 5, , Czech Republic
Praha, , Czech Republic
People applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
Discussion 0